90 years without a generic medicine for Insulin

In our previous posts we talked about generic medicines for hepatitis c in Spain but there are other diseases that haven’t got a generic equivalent such as Insulin. A generic version of insulin, the only medicne for diabetes has never been  available in the United States because pharmaceutical companies have made incremental improvements that have kept the insulin as a patent since 1923.

As a result, many who need insulin to control diabetes can not afford it and some end up hospitalized with life-threatening complications such as kidney failure and diabetic coma, according to the authors of a study published in ‘The New England Journal of Medicine’ . The researchers describe the history of insulin as an example of «perpetuation», in which pharmaceutical companies make a number of improvements to important medicines that extend their patents for many decades. This keeps previous versions outside the generics market, the authors say, because generic manufacturers have less incentive to make a version of insulin that physicians perceive as obsolete.

The new versions are slightly better for patients who can afford them, according to the authors, but those who cannot pay end up suffering painful complications. «We see generics as a rare success story, providing better quality at a cheaper price,» says Jeremy Greene, associate professor of the History of Medicine at the School of Medicine, Johns Hopkins University, USA Professor, «And we see the progression of patented drugs to generic drugs as almost automatic. But the history of insulin highlights the limits of generic competition as a framework for the protection of public health,» he adds. Over 20 million Americans have diabetes, a disease in which the body can not properly use the sugar in food due to insufficient insulin, a hormone produced in the pancreas.

Diabetes can be controlled without drugs or oral medications, but some patients require daily insulin injections. The drug usually cost between 120 and 400 dollars a month without insurance for prescriptions. «Insulin is an inappropriate medicine even for people who can afford one, says the report’s author, Kevin Riggs, a researcher in genral internal medicine and Berman Bioethics Institute at Johns Hopkins–. When people can not afford, often stop taking it altogether. » Patients with diabetes who are not taking their Insulin have problems with blurred vision, weight loss and intolerable thirst, symptoms of uncontrolled diabetes, which can lead to blindness, kidney failure, gangrene and loss of limbs.

These two doctors decided to find out why nobody makes generic insulin. A medical team from the University of Toronto, Canada, discovered insulin in 191, and in 1923, the university, which obtained the first patent, gave the pharmaceutical companies the right to manufacture and patent any improvement. In the 1930s and 1940s, pharmaceutical companies developed long-acting forms that allowed most patients get a single daily injection and in 1970 and 1980, manufacturers improved the purity of insulin extracted from cows and pigs, and from then, several companies have developed synthetic analogues.

The current standard in the US is Insulin Biotech, say the authors. Patents on the first synthetic insulin expired in 2014, but these new forms are harder to copy, so no patented versions will go through an approval process of the US drug agency (FDA, for its acronym in English) and It cost more to make them. When these insulins reach the market, they can cost 20 or 40 percent less than patented versions.